FDA device listing
DR-ID 1280,DR-ID 1281SE,DR-ID 1282SE,DR-ID 1283SE,DR-ID 1284SE,DR-ID 1285SE,FDR D-EVO II C24 (DR-ID 1213SE),FDR D-EVO II…
FDA device listing 1652599178 · FUJIFILM CORPORATION
Key facts
| Proprietary names | DR-ID 1280,DR-ID 1281SE,DR-ID 1282SE,DR-ID 1283SE,DR-ID 1284SE,DR-ID 1285SE,FDR D-EVO II C24 (DR-ID 1213SE),FDR D-EVO II C35 (DR-ID 1211SE),FDR D-EVO II C43 (DR-ID 1212SE),FDR D-EVO II (DR-ID1200),FDR D-EVO II Flat Panel Detector System (DR-ID1200),FDR D-EVO II G35 (DR-ID1201SE),FDR D-EVO II G43 (DR-ID1202SE),FDR ES C35 (DR-ID1273SE),FDR ES C43 (DR-ID1274SE),FDR ES(DR-ID 1270),FDR ES G35… |
|---|---|
| Owner/operator | FUJIFILM CORPORATION |
| Owner/operator number | 8031568 |
| Premarket submissions | K142003 |
| Product codes | MQB |
| Device names | MQB - Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1680 |
| Review panels | Radiology |
| Registered establishments | FUJIFILM CORPORATION, FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office |
| Establishment registrations | 3001722928, 3003775006 |
| FEI numbers | 3001722928, 3003775006 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database